US Food and Drug Administration has observed "increased risk" of a rare neurological disorder.
Washington, United States:
The US Food and Drug Administration on Monday updated its warning labels for the Johnson & Johnson Covid-19 vaccine to include information about an observed "increased risk" of a rare neurological disorder.
Based on analysis of a federal vaccine safety monitoring system, officials have identified 100 preliminary reports of Guillain-Barre Syndrome after approximately 12.5 million doses administered, people familiar with the matter said.
Of these reports, 95 of them were serious and required hospitalization. There was one reported death.
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